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CDER, CDRH Currently Writing Theranostics Draft Guidance for Jointly Marketed Products


The head of the FDA’s Center for Drug Evaluation and Research and the director of the agency’s Office of In Vitro Diagnostics are currently co-writing a new draft guidance on the use of jointly marketed diagnostic-therapeutic products, SNPtech Pharmacogenomics Reporter has learned.

The news, which comes following the release of two related draft guidance documents, is aimed at meeting head-on the rise of so-called theranostics products. Microarrays are widely expected to play a pivotal role in the development of such products.

CDER head Janet Woodcock and OIVD director Steven Gutman have been working on the new guidance very recently, Woodcock told SNPtech Pharmacogenomics Reporter, BioArray News’ sister publication. She intim-ated that it was the obvious next step in the FDA’s growing understanding of array-based technologies, and of the ways in which pharmaceutical companies have been using the products to discover and develop drugs.

The decision to draft the new guidance is also the latest stepping stone in the agency’s goal of regulating the collection and analysis of microarray data as an increasing number of drug makers begin using the technology more earnestly.

The agency has not determined when the new draft might be released for comment, but Woodcock suggested a final version might be ready in the fall. “We started … the process, but it’s going to be a while,” Woodcock said.The new document will focus on “joint development” issues behind theranostic models. For example, she said, the draft will seek to answer questions such as:’What do you actually do if you are developing a test and a drug in parallel?’ and you want them to come out even at [the regulatory] end … [where] the drug label says, ‘Use this test.’”

The FDA’s Center for Devices and Radiological Health, which oversees OIVD, would approve the test. “So we want to explain how that would work and what you should do and what studies you should do and everything so that people have a clear path,” Woodcock said.

She said the joint-development draft would be geared to theranostic pairings similar to Herceptin, but said that the immunohistology-based diagnostic used with this drug “will not be subject” to suggestions in the new draft guidance. However, “any kind of pharmacogenomic diagnostic” will be allowed — including analyte-specific reagents, that rely on microarray technology — she said.

— Kirell Lakhman, editor, SNPtech Pharmacogenomics Reporter